Collection: Fast Track Requests
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FDA Device Info: List of Devices Cleard by PMA Pathway
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: list of Single Use Devices
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: List of New 510k Devices Approved
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K961321, GAMMA GUIDANCE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083475, LUCENT MAGNUM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141316, COGNISION EEG/EP SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042600, STANSION MATRIX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K081331, FIXXSURE CROSS LINK
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111166, A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133340, SPINEWORKS ANTERIOR LUMBAR DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061079, MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K863920, WAKO(TM) ZN TEST
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K200225, Arctic Sun Stat Temperature Management System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161602, Arctic Sun Temperature Management System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142702, Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101092, ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071341, MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002577, ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K110456, PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121270, BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K032958, PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131817, EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K812558, TISSUE-TEK III ACCU-CUT ROTARY MICROTOME
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K102365, MICROPLEX COIL SYSTEM- COSMOS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K841695, CRAWLER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K980962, BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143054, Sherpa Pak Kidney Transport System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051814, JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142564, JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K182531, ClotTriever Thrombectomy System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K180722, CAPERE Thrombectomy System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K180329, ClotTriever Thrombectomy System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K190925, HeartFlow FFRct Analysis
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091035, FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K963064, ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K171771, ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
Regular price $149.00 USDRegular priceUnit price / per